Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd., EPS 8047, Rockville, MD 20852, USA.
J Clin Epidemiol. 2012 Dec;65(12):1296-9. doi: 10.1016/j.jclinepi.2012.07.010. Epub 2012 Sep 13.
To characterize current efforts and outcomes of individual patient data (IPD) collection among meta-analysts of randomized controlled clinical trials.
Corresponding authors of meta-analyses of randomized controlled trials in general medicine with a binary endpoint were sent an e-mail survey inquiring about their efforts to obtain IPD. Descriptive statistics of each meta-analysis were extracted to evaluate their association with data seeking.
Only 22 (4.2%) of the sampled meta-analyses included IPD. Of the 360 authors surveyed, 256 (71%) reported not seeking IPD: 48% thought that the undertaking would be too difficult, 30% thought that it was not necessary for their main analysis, 25% did not have sufficient time or resources, and 22% never considered it. Seeking IPD was not significantly associated with any trial characteristic examined, including whether subgroup analyses were performed. Authors who sought IPD obtained a median of two data sets (interquartile range=0-5). Unsuccessful contact (43%), refusal without explanation (21%), and lost or inaccessible data (20%) were the most common reasons why trial data could not be obtained.
The infrequency of attempts made by meta-analysts to obtain participant data is an important contributor to the rarity of IPD meta-analyses.
描述随机对照临床试验荟萃分析中个体患者数据(IPD)收集的现状和结果。
向一般医学中具有二元结局的随机对照临床试验荟萃分析的通讯作者发送电子邮件调查,询问他们获取 IPD 的努力情况。提取每个荟萃分析的描述性统计数据,以评估其与数据检索的相关性。
仅 22 项(4.2%)抽样荟萃分析纳入了 IPD。在接受调查的 360 位作者中,有 256 位(71%)表示未寻求 IPD:48%的人认为这项工作太难,30%的人认为其对主要分析没有必要,25%的人没有足够的时间或资源,22%的人从未考虑过。寻求 IPD 与所检查的任何试验特征均无显著相关性,包括是否进行了亚组分析。寻求 IPD 的作者平均获得了两个数据集(中位数[四分位距]:0-5)。无法获得试验数据的最常见原因是无法联系(43%)、无解释的拒绝(21%)和丢失或无法访问的数据(20%)。
荟萃分析者尝试获取参与者数据的频率较低,这是 IPD 荟萃分析罕见的一个重要原因。